Clinical Trials - Regulations - Briefed

CFR

The Code of Federal Regulations is an annual codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles representing broad areas subject to Federal regulation. Each Title is divided into chapters that are assigned to agencies issuing regulations pertaining to that broad subject area. Each chapter is divided into parts and each part is then divided into sections — the basic unit of the CFR. The purpose of the CFR is to present the official and complete text of agency regulations in one organized publication and to provide a comprehensive and convenient reference for all those who may need to know the text of general and permanent Federal regulations.

HIPAA

HIPAA ( Health Insurance Portability and Accountability Act) Refers to United States legislation of 1996 (privacy rules effective April 14, 2003) that requires health care providers and others to obtain written authorization from patients or their legally authorized representatives before using or disclosing their Protected Health Information (PHI) for many purposes other than treatment, billing, quality assurance, and education. Research is one of the activities for which written authorization is required in most cases.

ICH

International Conference on Harmonization, is a a joint initiative involving both regulators and industry from Japan, European Union, and United States as equal partners in the scientific and technical discussions of the testing procedures, which are required to ensure and assess the safety, quality and efficacy of medicines.

IFAPP

(International Federation of Associations of Pharmaceutical Physicians).The Federation is a non-profit organization, has existed since 1975 and has 29 Member Associations world-wide. The aim of the Organization is to act as an international forum for all the organizations of Pharmaceutical Physicians world-wide by dealing with matters brought to its attention by its National Member Associations. The IFAPP fosters the development and international recognition of Pharmaceutical Medicine as a medical specialty and the development of training and continuing education programs in pharmaceutical medicine. It stimulates a closer relationship between the Member Associations and an improved understanding between the Associations and the medical and allied professionals, regulatory authorities etc.

…..This is not it…its just the beginning…watch out for more on Regulations…